Effects of Semi-standarized Acupuncture in Chronical Symptomatic Osteoarthritis of the Knee Through: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 主要终点
- Change from Baseline Pain at post intervention
研究概览
简要总结
Introduction:
Knee osteoarthritis is a long-term rheumatic disease with a significant impact on the patient's quality of life and the socio-economic development of societies. The usual treatment consists of non-steroidal anti-inflammatory drugs as a palliative measure. The decrease in the beneficial effect and the appearance of serious long-term adverse effects make it necessary to look for other therapeutic procedures. Acupuncture is a non-pharmacological treatment that could reduce pain and improve functionality in this condition, however current scientific evidence is limited. A previous study has observed a clinical improvement in the combination of sensitized local and peripheral points in the treatment of knee osteoarthritis but studies with a larger sample are needed to confirm these results.
Objective:
Assess the effectiveness of acupuncture using a combination of local and peripheral sensitized points in the treatment of active knee osteoarthritis.
Methods:
A randomized clinical trial will be performed in a hospital centre with 2 groups. The control group will standard treatment plus transcutaneous electrical nerve stimulation, while the intervention group will receive acupuncture in addition to standard care. Study outcomes will be pain, quality of life, function, exercise adherence, drug intake, adverse effects, and body mass index. There will be a 12-month post-intervention follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Usual painful episode of 3 months or more
- •Morning stiffness of 15 minutes or more
- •Pain equal to or greater than 5 on the VAS
- •Grade 2 or greater on the Kellgren-Lawrence scale
排除标准
- •Corticosteroid infiltration in the 3 months prior to recruitment
- •Rehabilitation treatment one month prior to recruitment
- •With a knee prosthesis
- •Needle phobia
- •Pregnancy
- •With pacemakers
- •Cardiac arrhythmias
研究组 & 干预措施
Usual care plus TENS
Participants in this group will receive transcutaneous electrical nerve stimulation (TENS) and usual care.
TENS treatment will perform in the region of the knee and the extensor muscles for 20 minutes, 2 times a week. 4 electrodes will be placed, 2 on the proximal region of the internal and external vastus, and the other 2 on the distal region of the motor plate.
Usual care will consist in home exercises with toning exercises of the extensor apparatus, pelvic region and musculoskeletal stretching exercises of 2 weekly sessions, the recommendation of daily activity of walking for 1 hour daily as an active lifestyle and the recommendation of the reduction of body weight in the case of being above normal weight. There will be a total of 6 face-to-face sessions at the rate of 2 weekly sessions
干预措施: TENS (Device)
Usual care plus Acupuncture
Participants in this group will receive acupuncture treatment and usual care.
Acupuncture treatment will consist in 20-minute semi-standardized acupuncture sessions, 2 times a week. The intervention will consist of the insertion of 8 needles: 4 in points located in the knee (points St34, St35, XiYan and Sp10) and 4 more sensitive to palpation points located between the knee and the ankle. Stimulation will be performed to obtain local spasm response, the needles will be left for 20 minutes and then removed. The needles will be sterile disposable silicone needles of 0.20x20mm and 0.20x40mm.
Usual care will be the same described in the Usual care plus TENS group
干预措施: Acupuncture (Other)
结局指标
主要结局
Change from Baseline Pain at post intervention
时间窗: At the end of the intervention, at the 4th week of the study
Pain will be assessed using the visual analogue scale (VAS)
Change from Baseline Quality of life at postintervention
时间窗: At the end of the intervention, at the 4th week of the study
Quality of life will be assessed using the SF-12 questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Change from Baseline Knee function at postintervention
时间窗: At the end of the intervention, at the 4th week of the study
Knee function will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
次要结局
- Change from Baseline Knee function at 4 months(16 weeks afther the end of the intervention, at the 20th week of the study)
- Change from Baseline Quality of life at 4 months(16 weeks afther the end of the intervention, at the 20th week of the study)
- Change from Baseline Pain at 4 months(16 weeks afther the end of the intervention, at the 20th week of the study)
- Adverse events postintervention(through study completion, an average of 1 year)
- Drug intake postintervention(through study completion, an average of 1 year)
研究者
Tomás Tegiacchi
Principal Investigator
Universitat de Girona